Statement of Work.pdf

VISN 19 PROSTHETIC LIMBS

STATEMENT OF WORK

1.0 Background

i. The Department of Veterans Affairs (VA) provides custom and off the shelf orthoses and prosthetic limbs and related services to Veterans who are eligible for VA health care services and have medical needs for such items and services. This acquisition will supplement VA in providing comprehensive prosthetic & orthotic care and support to Veterans in need. It is VA’s intent to solicit and award multiple contracts to responsible contractors under the authority of Title 38 U.S.C. Section 8123.

ii. The services shall be provided to the following facilities: (1) VA Eastern Colorado Health Care System, Denver, CO; (2) VA Montana Health Care System, Fort Harrison, MT; (3) VA Salt Lake City Health Care System, Salt Lake City, UT; (4) Cheyenne VA Medical Center, Cheyenne, WY; (5) Grand Junction Health Care System, Grand Junction, CO; (6) Sheridan VA Medical Center, Sheridan, WY (7) Oklahoma City VA Health Care System, Oklahoma City, OK (8) Muskogee VA Medical Center, Muskogee, OK.

iii. The VISN 19 VA Medical Centers (VAMCs), on a combined basis, are expected to request approximately 450 new prosthetic legs, 100 new prosthetic arms, 25,000 pair of shoes and orthotics and 47,000 various orthoses and 7,000 Orthotics and Prosthetic (O&P) repairs per year throughout the (5) five-year period. These estimates cover all contracts issued not any one individual contract.

iv. ABBREVIATIONS:

ABC - American Board for Certification in Orthotics and Prosthetics

BOC - Board for Orthotist-Prosthetist Certification (Accredited Facilities Program)

CO – Contracting Officer

COR – Contracting Officer Representative

DMEPOS – Durable Medical Equipment Prosthetics, Orthotics, and Supplies FAR – Federal Acquisition Regulation

HIPAA – Health Insurance Portability and Accountability Act CMS - Center for Medicare and Medicaid Services

HCPCS - Healthcare Common Procedure Coding System L-CODE - CMS Codes for Orthotics and Prosthetics NOC – Not Otherwise Classified or Specified

O&P - Orthotics and Prosthetics

QASP – Quality Assurance Surveillance Plan TJC – The Joint Commission

USC – United States Code

VA - Department of Veteran Affairs VAMC – Veteran Affairs Medical Center

v. DEFINITIONS:

a. Good Standing: Participates and achieves appropriate continuing education credits and pays dues as determined by Certifying Agency such as ABC or BOC.

b. Fee Schedule: CMS issues regional payment amounts for prosthetics and orthotics on a semiannual basis; the fee schedule that is current on the date the order is placed will be used for the VA Contracted discount rate per state.

c. Lxx99: codes ending in 99 are used for components that have not been assigned a HCPCS or a Fee Schedule reimbursement amount by CMS.

2.0 Scope

i. The Contractor shall fabricate all prosthetic limbs in strict conformance to the prosthetic prescription that has been provided by the VA Amputee Clinic Team. VA will provide a list of approved L Codes for work to be provided by the Contractor for the specific prescription. The Contractor shall not add or substitute components or alter the veteran’s limb prescription in any way without prior approval and written authorization from the Contracting Officer Representative (COR). The solicitation only includes commercial items. Products that are not commercial items are considered experimental and purchase of experimental products shall not be authorized under this solicitation. The Contractor shall fabricate the artificial limbs or orthotic device in strict conformance to the prosthetic prescription that has been provided by the VA. Contractors shall not add or substitute components or alter the beneficiary’s limb or orthotic prescription in any way without prior approval from the VA.

3.0 Education and Training Requirements

i. The Contractor shall have a full-time American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC) certified, or Board of Certification/Accreditation International (BOC) certified prosthetist(s) on staff in “good standing” at each of the proposed service locations throughout the contract period. “Good standing” is defined as participating and achieving appropriate continuing education credits and paying dues as determined by Certifying Agency such as ABC and BOC.

ii. VA reserves the right to verify Certified Practioner’s credentials anytime during the term of this contract, see FAR Clause 52.212-4 paragraph (m).

iii. Within 10 calendar days after award of the agreement, the Contractor(s) shall provide the Contracting Officer (CO)/Contracting Officer Representative (COR) with a list of all employees involved in any portion of this agreement. Each employee’s listing shall indicate all training applicable to this agreement. Photocopies of training/accreditation certificates for each current and future employee(s) shall be provided with the employee list.

iv. The Contractor(s) shall notify the Contracting Officer (CO)/Contracting Officer Representative (COR) in writing within (7) seven calendar days of new or reassigned employees and submit the required photocopies of documentation of training throughout the life of the agreement.

v. The Contractor shall provide current copies of certifications upon request of the COR. Failure to comply with this requirement may lead to adverse actions by the Government up to and including contract termination in accordance with the contract clauses in the contract.

3.1. Special Education Requirements for Certain Prosthetic Limb Devices/Components

The fitting and alignment of prosthetic limbs devices, high-tech prostheses, and associated services shall be performed by or under the supervision of a Board Certified Prosthetist or Board Certified Orthotist who has met the applicable educational and training requirements covered under the manufacturing training program for that device. New technologies require proof of training and only those prosthetists specifically trained or completing training for purposes of providing an item by the time of delivery of the item may provide the item and follow up services to a veteran. VA reserves the right to determine which technologies require specific training. VA will notify the Contractor when current technologies require specialized training from the manufacturer in order to provide to veterans. The Contractor must be able to provide prosthetic and orthotic devices regardless of level of technology.

4.0 Specific Requirements

i. The contractor(s) shall be required to attend clinic meetings at the facility they service when requested to attend.

ii. Solicitation of Beneficiaries - The contractor(s) agrees not to directly or indirectly through agents/and or clinicians solicit eligible Veteran beneficiaries.

iii. VA personnel shall not direct, guide, or prompt a Veteran beneficiary to a specific contractor except when a physician determines that it is a medical necessity. To assist in the selection of their Prosthetist, all eligible Veteran beneficiaries shall be given a current list of “preferred providers – awarded a Contract” - located within the VISN Medical Center jurisdiction. The list of “preferred providers” shall contain the following header statement in boldface type.

“YOU HAVE THE RIGHT TO SELECT THE ARTIFICIAL LIMB CONTRACTOR OF YOUR CHOICE FROM ANY OF THE VA APPROVED CONTRACTORS. ANY ATTEMPT TO INFLUENCE YOUR DECISION OR TO DIRECT YOU TO ANY PARTICULAR CONTRACTOR SHOULD BE REPORTED TO THE MEDICAL CENTER DIRECTOR OF THIS

FACILITY.”

iv. It is currently the policy of the VA that Veterans with continuing eligibility have the option of choosing a provider of choice.

4.1. Compliance with VA Prescription and Coding of Prosthetic Limb Devices/Components

The Contractor shall not add or substitute components or alter the veteran’s prosthetic limb prescription in any way without prior approval and written authorization from the CO. Any changes to the veteran’s prescription, components or codes require review and approval by the VA Amputee Clinic Team and shall be authorized in writing by the CO.

4.2. Contractor Facility Locations

All Contractor facilities as well as other fabrication facilities such as commercial central fabrication facilities that will be utilized for this contract shall be listed in the quote. All work required under this contract shall be conducted at the facility locations included in the contract. The Contractor’s facilities shall be accredited either by the Facility Accreditation Program of the ABC or the Accredited Facilities Program of the BOC at the time of quote submission. VA reserves the right to conduct site visits of the facility and review accreditation and certification documents and standards at any time. The Contractor shall provide current copies of accreditation documents upon request of the COR. VA may conduct site visits as needed by the COR and other VA subject matter experts as determined by the COR. Throughout the duration of this contract, the Contractor shall notify VA of any facilities that are added, changed, or closed to the CO and the COR within 15 calendar days of any change. Approval for added or changed facilities must be obtained before those facilities may be used for this contract.

4.3. The Joint Commission and Other Special Requirements

The Contractor shall perform the required work in accordance with The Joint Commission (TJC) and ABC and/or BOC standards. All Contractor employees shall continuously meet or exceed TJC and ABC and/or BOC standards. The Contractor shall develop and maintain the following documents for each contractor employee working on this contract: credentials and qualifications for the job; a current competence assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully, and including knowledge and skills required to provide care for certain patient populations, as appropriate); a current performance evaluation supporting ability of the contractor employee to successfully perform the work required under this solicitation; and, listing of relevant continuing education for the last two years. At the time of contract award, annually on the date of the contract award thereafter, and at any other time requested by the VA COR, the Contractor shall provide current copies of these records for each contractor employee working on this contract.

The Contractor shall be responsible for ensuring that contractor employees providing work on this contract are fully trained and completely competent to perform the required work.

When changes in contractor personnel are approved in accordance with the “Key Personnel” clause of the contract in section 5.1, the Contractor shall provide evidence of orientation, the current competence assessment, and current performance evaluation that supports the above.

Where the contract does not require TJC accreditation or other regulatory body requirements, the Contractor shall perform the required work in accordance with TJC standards. A copy of TJC standards can be obtained from The Joint Commission, One Renaissance Blvd., Oakbrook Terrace, IL 60181 or http://www.jointcommission.org/.

4.4. Outcome Monitoring and Utilization

VA may prescribe and authorize an automated prosthetic utilization and function monitoring device for data collection and analysis for a new lower extremity prosthetic limb (transtibial, knee disarticulation, transfemoral and hip disarticulation level; does not include socket replacements). The utilization and function monitoring device will have the ability to record intensity, endurance, gait symmetry, dynamic function, including alignment, forces and moments with proven accuracy.

The device will monitor and continuously record the following:

• Stance and swing time for gait symmetry, dynamic function including alignment, forces, and moments;

• Cadence and cadence variability;

• Step count – continuous recording of total step count;

• Number of steps per selected time interval;

• Longitudinal, historical and objective analysis;

• Peak performance index, quantifiable into baseline and faster than baseline rate of walking, distance and variable cadence;

• Functional level assessment capability; and

• Measurement of socket load during gait.

VA may request “Veteran Outcome Reports” based on the data collected. The report shall contain narrative and graphical representation of the above variables. The Contractor shall be paid subject to the following guideline for a utilization and function monitoring device and associated report(s):

1. CMS HCPCS L5999 (lower extremity prosthesis, not otherwise specified – outcome device(s)) code shall be used to reimburse the Contractor for the utilization and function monitoring device.

2. Total reimbursement for the device and outcome report(s) will be reimbursed in accordance with the NOC L-Code item reimbursement guidelines. The total reimbursement includes the device and outcome report(s). Outcome report(s) requested by VA shall not be reimbursed separately.

3. This is a one-time billable charge for the utilization and function monitoring device and associated outcome report(s) for new prosthetic limbs only.

4.5. Not Otherwise Classified or Specified L-Codes

A Not Otherwise Classified or Specified (NOC) device is a prosthetic limb device/component that has not been assigned a CMS HCPCS code or received a HCPCS determination and is mass manufactured and commercially available through manufacturers (e.g., newer prosthetic knee units, prosthetic feet, liner technologies, prosthetic terminal devices, etc. that CMS has not yet evaluated for allowable rates).

These items will only be reimbursed, provided an invoice showing purchase from the manufacturer is provided to the VA.

The CMS HCPCS contains two Not Otherwise Classified or Specified (NOC) L-Codes for prosthetic limbs, L5999 and L7499. VA recognizes only these NOC L-Codes for use with lower and upper extremity prosthetic limbs and modification of the NOC L-Code language is not permissible:

• L5999 – Lower extremity prosthesis, not otherwise specified

• L7499 – Upper extremity prosthesis, not otherwise specified

The NOC L-Code is all inclusive and therefore, only one NOC L-Code is authorized per component.

Multiple NOC L-Codes may be utilized per prosthetic limb, which is comprised of multiple components.

For example, if a lower extremity prosthetic limb is being ordered with a NOC L-Code prosthetic knee and a NOC L-Code prosthetic foot, it is permissible to authorize a NOC L-Code for each component, the prosthetic knee and the foot. However, no other L-Codes will be authorized with these NOC L-Codes that would further describe the component, such as a labor L-Code or an L-Code for an additional functionality on the same component. The Contractor understands that VA retains sole discretion to determine whether a component or device would classify for a NOC L-Code designation.

For NOC L-Codes that do not have L-Code fee schedule published by CMS HCPCS, the Contractor shall be paid subject to the following guidelines:

a. For an item or service that is classified in the CMS HCPCS, the Contractor shall be paid the lesser of the L-Code amount, minus the discount rate, or the VA Contracted discount rate per state.

b. For an item or service that is not otherwise classified in the CMS HCPCS, VA Central Office, at its discretion, will temporarily assign an existing similar CMS HCPCS L-Code that best matches the description of the NOC item, or VA Central Office will assign L5999 or L7499 until CMS assigns a HCPCS L-Code with fee schedule.

c. For cases where the VA has temporarily assigned an existing CMS L-Code, the Contractor shall be paid the lesser of the CMS L-Code rate, minus the applicable discount, or the VA Contracted discount rate per state.

d. For cases where the VA temporarily assigns L5999 or L7499, the Contractor shall be paid

1.5 times the Contractor’s purchase invoice price from the manufacturer for the item, minus any applicable discount only if the invoice cost of the prosthetic component is less than $6,666.66.

($10,000.00 Total)

4.6 Payment For High Tech Repairs

There will be no charge to the VA for warranty repairs.

VA must prior approve repairs to high tech components no longer under warranty. The Contractor(s) shall give VA a copy of the manufacture’s quote for the repair. If the repair is approved, VA will then pay the amount the manufacturer quoted plus usual and customary cost of labor determined/approved by VA (L7520 for prosthetics or L4205 for orthotics).

4.7 Performance, Delivery, Inspection And Acceptance

i. Performance and Delivery

a) The Contractor shall complete initial delivery of items ordered under this contract no later than 30 calendars days after receipt of a delivery order, unless unusual circumstances approved by VA.

Contractor must notify VA of any issues with circumstances that will delay delivery within 5 business days. Initial delivery means an ordered item or service is complete and the item is provided to and accepted by the patient. The Contractor shall provide a written notification to the CO within 7 calendar days of the receipt of a delivery order to show cause in the event the Contractor is unable to deliver the required items or services in accordance with the Government’s required delivery date. Initial delivery shall not be construed as final delivery or acceptance of an item or service by the Government.

In the event the Government desires expedited delivery, the CO shall telephonically contact the Contractor and inquire into the feasibility of obtaining the device under this condition. The Contractor shall respond within 24 hours to such request and expedited delivery shall be mutually agreed upon.

Expedited delivery terms and conditions, when required, shall be determined by the CO or COR and the Contractor on a case by case basis and stated in the individual task or delivery order. Any additional costs incurred by the Contractor for meeting this requirement shall be negotiated in accordance with 48 U.S.C. 52.212-4, Contract Terms and Conditions – Commercial Items. The total cost for the expedited delivery shall not exceed 1.5 times the cost of the normal delivery for the same or similar item with any applicable discounts. Failure by the Contractor to deliver the ordered items on an expedited basis, or otherwise fulfill the agreed upon requirements shall constitute an event of default, and the CO shall undertake any action authorized pursuant to the awarded contract, or otherwise in accordance with applicable statutes and regulations.

ii. Inspection and Acceptance

a) Contractor performance shall be monitored by the indicators listed below. The indicators are:

• Delivery time requirement

• Limb compliant with VA physician prescription

• Workmanship free of defect (socket fits appropriately, limb correctly aligned)

• Patient education

• Patient acceptance of the device in all aspects (cosmetically and functionally)

Payment shall be rendered for a prosthetic limb or service that satisfactorily meets all of the indicators.

Payment shall be delayed for any prosthetic limb or service that does not meet one or more of the indicators. The Contractor shall correct all deficiency of non-compliant prosthetic limb or service within fifteen (15) calendar days of written rejection notification from the COR. The corrected prosthetic limb or service will be re-inspected for acceptance. No invoice shall be submitted until the Government accepts the item or service.

For new prosthetic limbs or socket replacement for existing prosthetic limbs, final check-out by the VA Amputee Clinic Team at the VAMC from which the task order was generated is required. Final delivery and check out shall be conducted at the VAMC, either by in person inspection or via Tele-health capabilities at an outlying VA facility. Final acceptance or rejection and authorization for payment shall occur with the final delivery and checkout of the prosthetic limb to ensure accuracy of prescription and acceptance by the veteran. CO will provide a written acceptance notification for any items accepted by the Government. Veteran prosthetic limb wearers may be measured and fitted and accept conditional or initial delivery of the prosthetic limb at the Contractor’s facility. However, conditional or initial delivery shall not be construed as final delivery or acceptance of an item or service by the Government and authorization for payment.

Repair or replacement of prosthetic limb components other than socket replacement does not generally require final check-out by the VA Amputee Clinic Team unless VA determines and notifies the Contractor that the final check-out is required with the issuance of the task or delivery order. VA retains sole discretion to determine whether a final check-out is necessary for the task order.

iii. The VA shall require the Contractor(s) to deliver items ordered under the terms and conditions of the multiple award Contract. The Contractor is required to provide appointments to referred patients within (7) seven calendar days and deliver items ordered under this agreement no later than 30 calendar days after acceptance of a purchase/delivery order. Contractor must notify VA of any issues with circumstances that will delay delivery within 5 business days. The Contractor(s) shall notify the VA Prosthetic Representative and show cause in the event he is unable to deliver the required items in accordance with the Government’s required delivery date.

iv. Receipt of a purchase order constitutes acceptance of that order unless the Contractor provides a written notification of non-acceptance within (3) three workdays after receipt.

v. Quotes for custom items from the Contractor must be reviewed and approved by a VA Prosthetist or Orthotist before the purchase order is placed. Work shall not be started until a purchase order is received. Purchase order for all items will be on VA Form 10-2421PC, Prosthetic Authorization for Items or Services. Quotations requested by VA of the Contractor shall be responded to within 10 calendar days.

vi. Expedited delivery shall be mutually agreed upon. Any additional costs incurred by the Contractor for meeting this requirement shall be negotiated in accordance with clause 52.212- 4, Contract Terms and Conditions – Commercial Items. (Note: Expedited Delivery terms and conditions, when required, will be determined by the Contracting Officer (CO), Contracting Officer Representative (COR) or Ordering Officer on a case by case basis and stated in the purchase card order).

vii. There will be no additional charge for visits to Veterans who are inpatients in VA Medical Centers or VA Nursing Homes.

viii. Unless otherwise specified on the order delivery, the service will be made to the Veteran.

ix. The Contractor shall obtain a signature and date from the Veteran at the time of delivery certifying the Veteran’s receipt of the device or service. Receipt of the device or service does not constitute acceptance of the device or service. A 30 day trial period will occur to determine proper fit function and satisfaction of the device or service. After the 30 day trial period the Contractor will submit a Statement of Satisfaction of the device or service to VA.

x. For new prosthetic limbs or socket replacement for existing prosthetic limbs, final check-out by the VA Amputee Clinic Team at the VAMC from which the delivery order was generated is required. After the final check-out by the VA Amputee Clinic Team and VA acceptance of the item or service, a copy of the signed and dated invoice shall be provided to the COR within 30 calendar days of the VA acceptance of the item or service. Repair or replacement of prosthetic limb components other than socket replacement does not generally require final check-out by the VA Amputee Clinic Team unless VA determines and notifies the Contractor that the final check-out is required with the issuance of the delivery order. VA retains sole discretion to determine whether a final check-out is necessary for the delivery order.

4.8. Semi-Annual Service

The Contractor shall provide semi-annual service to each veteran for whom the Contractor is managing prosthetic limb care. For the purposes of this contract, semi-annual service is defined as a follow up visit for inspection of the prosthetic limb(s) and evaluation for fit and function for all VA-approved prosthetic limb(s) the patient owns and is actively using. Typically, semi-annual service includes inspection, testing, cleaning, and checking of the prosthetic limb(s) and/or residual limb(s) to include maintenance specific to the warranty of devices.

Semi-annual service shall not be incumbent upon the number of prosthetic limbs a patient owns. Two follow up visits per patient are required annually for a patient to whom the Contractor delivered a prosthetic limb(s) under this contract. The Contractor shall notify the CO for the required semi-annual service and receive written authorization prior to providing the semi- annual service to the veteran.

The following L-Code shall be used for semi-annual service:

• L7520 – Repair prosthetic device, labor component, per 15 minutes (not to exceed 4 units or 60 minutes)

4.9. Warranty

The Contractor shall warrant the prosthetic limb provided against defective material and/or workmanship for a minimum of 90 calendar days from the date of acceptance by VA. The minimum warranty period shall commence after the final check out at the VAMC by the Amputee Clinic Team and deliverable acceptance by the CO. Manufacturer’s warranties of prosthetic limb and limb devices/components that extend beyond the minimum 90 calendar day period shall be in effect and be enforced. The Contractor shall furnish, without additional cost to the Government, all materials and labor necessary to correct defects that were detected during the warranty period. These conditions do not apply to adjustments incidental to wearing of the prosthetic limb, adjustments required by physical change of the wearer, or where there is evidence of deliberate misuse or alteration by anyone other than the Contractor.

Any prosthetic limb repaired or furnished as a “loaner” shall be subject to this clause to the same extent as a new prosthetic limb delivered. The warranty for a repaired limb or “loaner” limb shall be equal in duration to the term the Contractor is required to offer to a new prosthetic limb and shall run from the date of the acceptance of the repaired or “loaner” prosthetic limb by VA.

The Contractor shall warrant and imply that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract. The rights and remedies of the Government provided in this clause are in addition to, and do not limit any, rights afforded to the Government by any other clause of the contract.

4.10 Repair and Replacement

i. Repair and Replacement of Minor Parts of Prosthetic Device and Labor: The Contractor shall be reimbursed for repair and replacement of minor parts and labor as required by this solicitation utilizing the appropriate L-Codes. All repairs must be pre-authorized by VA. The Contractor shall not be reimbursed for a repair if a pre-authorization was not approved prior to the repair.

ii. After hours repairs without pre-authorization will be reviewed on a case by case basis by

VA

a. Normal Business Hours are Monday-Friday 8:00AM-4:30PM

4.11 Minor Parts of Prosthetic Device and Labor

All parts procured or fabricated to replace existing parts or to modify a previously issued or fabricated device is considered a “repair,” regardless of who fabricated or supplied the original part. Repair and replacement of minor parts may require adjustments to a prosthetic limb required by wear or a change in the veteran’s condition. A minor repair or replacement means repair or replacement that does not significantly alter the function or essential physical characteristics of an item or component or change the purpose of an item or component. Factors that will be considered in determining whether a repair or replacement is minor include the value and size of the repair or replacement, and the comparative value and size of the final product. Dollar values and percentages may be used as guideposts but are not conclusive evidence that a repair or replacement is minor. The following L-Codes shall be used for repair and replacement of minor parts and for labor:

• L7510 – Repair prosthetic device, repair or replace minor parts

a. Contractor required to submit invoice for replacement component.

• L7520 – Repair prosthetic device, labor component, per 15 minutes

a. Labor units is a case by case basis approved by VA.

Repair and replacement of minor parts and labor requires prior approval and written authorization from the CO.

4.12 Other than Repair or Replacement of Minor Parts of Prosthetic Device and Labor

Repairs to a prosthetic limb are covered when necessary to make the prosthetic limb functional. If the expense for repairs exceeds the estimated expense of purchasing a new prosthetic limb or device, no payment can be made for the amount of the excess. Maintenance that may be necessitated by manufacturer’s recommendations or construction of the prosthetic limb shall be performed by the Contractor covered as a repair.

Replacement of a prosthetic limb or replacement of a prosthetic limb device/component requires prior approval and written authorization from the CO. Replacement of a prosthetic limb or prosthetic limb device/component will be initiated if the VA provider (i.e., Amputee Clinic Team or VA provider) with granted prescription authority, and who is involved in veteran’s amputation care, prescribes a prosthetic limb or device for the following reasons:

(1) A change in the physiological condition of the patient; irreparable wear of the device or part of the device; or the condition of the device, or part of the device, requires repairs and the cost of such repair would be more than 60% of the cost of a replacement device, or of the part being replaced.

(2) Damage to the prosthetic limb or device is not due to malicious damage, culpable neglect, wrongful disposition or use of device other than intended purposes.

4.13 Government Supplied Items

VA may provide certain supplies such as shrinkers, liners, sleeves, and socks to the veteran at the discretion of the VA. Any items or supplies provided to the veteran by the Contractor shall be pre-authorized by the CO.

4.14 Loaner Prosthetic Limb Requirements

i. The Contractor shall be qualified to furnish prosthetic devices such as, but not limited to, hydraulic knee units, micro-processor feet and knees, electronic hands and feet by completing special educational and training requirement for such devices as described in section 3.0 and the same requirement shall be applied to provision of a “loaner” unit. The Contractor shall provide a “loaner” unit in the event that a veteran’s prosthetic limb requires repair by the manufacturer. A “loaner” is defined as a suitable prosthetic device, fit for patient use during the repair period. VA will not reimburse for loaner units.

ii. Loaner Microprocessor Joint – Contractor(s) who are qualified to furnish microprocessor joints are required to provide a “loaner” unit in the event that a veteran beneficiary’s unit needs repair by the manufacturer. Contractor(s) shall submit a copy of the invoice from the manufacturer to support the cost of repairing the malfunctioning unit. Any salvage value granted by the manufacturer for a non-repairable unit shall be credited to VA against the cost of a replacement unit. Some microprocessor joints may have up to a three-year warranty for parts from the manufacturer, which shall be credited to the VA. Contractor shall not be reimbursed for loaner units.

4.15 Salvage

In the event that a veteran beneficiary dies prior to delivery and acceptance of an artificial limb or orthosis, VA shall pay the contractor for the work performed up to the point that they are notified to stop work. The pricing paid shall not exceed the price of the limb less the salvage value of the unused limb.

4.16 Device Recall

i. The Contractor(s) shall immediately notify all effected VAMC (s), COR’s, and contracting activities in the event of a product recall, removal, required adjustment, or required modification that is suggested or mandated by the contractor, distributor, manufacturer, or any regulatory or official agency. The information that shall be included in this notification includes:

1. A complete item description, identification.

2. Administrative identification, data including contract number, order numbers, and order date.

3. Reasons for recall, removal, adjustment, or modification.

4. Instructions for appropriate corrective action

5.0 Special Contract Requirements

5.1 Key Personnel and Temporary Emergency Substitutions

The Contractor shall assign the following key personnel to this contract: all individuals providing items and related services to veterans and for whom information about education and training is required to be submitted as a part of the response to this solicitation including, but not limited to, those individuals who must meet the training requirements set forth in the Education and Training Requirements in Section 3.0.

During the first ninety (90) calendar days of performance, the Contractor shall make no substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment.

The Contractor shall notify the CO, in writing, within fifteen (15) calendar days after the occurrence of any of these events and provide the following information:

• Detailed explanation of the circumstances necessitating the proposed substitution;

• Complete resume for the proposed substitute; and

• Any additional information requested by the CO.

Proposed substitutes shall have comparable qualification to those of the persons being replaced. The CO will notify the Contractor within fifteen (15) calendar days after the receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel. In the case where VA does not agree with the proposed substitutes and their qualifications, the contract may be terminated, and the Contractor may not receive the minimum dollar amount specified in this contract.

For temporary substitutions where the key person will not be reporting to work for three (3) consecutive work days or more, the Contractor shall provide a qualified replacement for the key person.

This substitute shall have comparable qualifications to the key person being replaced temporarily. Any substitution exceeding a period of two weeks consecutively shall follow the key personnel replacement procedure described in paragraph above.

5.2 Confidentiality of Patient Records

The Contractor shall develop or operate a system of records on individuals, to accomplish an agency function subject to Title 5 United States Code (USC) 552a. Violation of the law may involve the imposition of criminal penalties. The Contractor may be required to enter into a Business Associate Agreement.

The Contractor is a VA contractor and shall assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. The contractor is considered to be a VA contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362.

Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the contract, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552

(FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. Records created by the contractor in the course of treating VA patients under this contract are the property of the VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations. Upon the expiration of this contract or termination of the contract, the contractor shall promptly provide the VA with the individually identified VA patient treatment records. In any instance where the contractor transmits patient or sensitive data of any sort to VA, the contractor shall encrypt the data and provide it in an encrypted/secured manner.

5.3. VA Sensitive Information

VA sensitive information is all Department data, on any storage media or in any form or format, which requires protection due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the information. The term includes information whose improper use or disclosure could adversely affect the ability of an agency to accomplish its mission, proprietary information, records about individuals requiring protection under various confidentiality provisions such as the Privacy Act and the HIPAA Privacy rule, and information that can be withheld under the Freedom of Information Act. Examples of VA sensitive information include the following: individually-identifiable medical, benefits, and personnel information; financial, budgetary, research, quality assurance;

confidential commercial, critical infrastructure, investigatory, and law enforcement information;

information that is confidential and privileged in litigation such as information protected by the deliberative process privilege, attorney work-product privilege, and the attorney client privilege; and other information which, if released, could result in violation of law or harm or unfairness to any individual or group, or could adversely affect the national interest or the conduct of federal programs.

6.0 Ordering Procedures

The Contractor shall not directly, or indirectly through agents, solicit eligible veterans. VA personnel shall not direct, guide or prompt a veteran to a specific contractor except when a physician determines that it is a medical necessary as documented in clinical notes.

Veterans are allowed to select a non-VA prosthetic limb provider from a list of VA approved contractors, and this satisfies the requirement for fair opportunity. In some instances, a VA clinician determines that it is medically necessary to select a certain contractor as documented in clinical notes, which would also satisfy the fair opportunity requirement of FAR 16.505(b)(1). Exceptions to the fair opportunity process are:

• The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

• Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

• The order must be issued on a sole-source basis in the interest of economy and efficiency because it is logical follow-on to an order already issued under the contract, provide that all awardees were given a fair opportunity to be considered for the original order.

• It is necessary to place an order to satisfy a minimum guarantee.

• For orders exceeding the simplified acquisition threshold, a statue expressly authorizes or required that the purchase be made from a specified source.

• In accordance with Section 1331 of Public Law 111-240 (15 USC 644(4)), contracting may, at their discretion, set aside orders for any of the small business concerns identified in 19.000(a)(3). When setting aside orders for small business concerns, the specific small business program eligibility requirements identified in part 19 apply.

7.0 QUALITY ASSURANCE: The Contractor shall have an on-going quality assurance program designed to monitor and evaluate the quality and appropriateness of patient care, resolve identified problems, and pursue opportunities to improve patient care objectively and systematically. The Contractor shall provide a copy of their ABC or BOC performance monitors each quarter.

8.0 SITE VISITS: An appointed VA Medical Center Team may conduct an inspection of the contractor’s facilities prior to and during the life of the contract. The Contractor(s) shall permit unannounced site visits by VA personnel and ABC, BOC, or Joint Commission surveyors accompanied by VA personnel to assess services, i.e. adequacy, compliance with contractor requirements, record keeping, etc. A written report of deficiencies as determined by the COR with any recommendations shall be submitted immediately to the contractor. Contractor shall make all VA patient(s) records accessible for review.

9.0 DELIVERY SCHEDULE: Services to be provided for and at the request of the following:

VISN 19 facilities:

1. Eastern Colorado Healthcare System

Chief, Prosthetic Treatment Center (121 JWL) VA Jewell Clinic

14400 E Jewell Ave Aurora, CO 80012

2. Grand Junction Health Care System

Chief, Prosthetics & Sensory Aids (90P) VA Medical Center

2121 North Avenue Grand Junction, CO 81501

3. VA Cheyenne

Chief, Prosthetics & Sensory Aids (121) VA Medical Center

2360 E. Pershing Blvd. Cheyenne, WY 82001

4. Salt Lake City Health Care System

Chief, Prosthetics & Sensory Aids (121)

VA Medical Center 500 Foothill Blvd. Salt Lake City, UT 84148

5. Montana Health Care System

3687 Veterans Drive Ft Harrison, MT 59636

6. VA Sheridan

1898 Fort Road Sheridan, WY 82808

7. Oklahoma City Health Care System

Chief, Prosthetics & Sensory Aids

921 N.E. 13th Street Oklahoma City, OK 73104

8. VA Muskogee

Chief, Prosthetics & Sensory Aids

1011 Honor Heights Drive Muskogee, OK 74401

10. DELIVERY ORDERS: All delivery orders placed against the Contract are subject to the terms and conditions of all the clauses and provisions in full text or incorporated by reference in this document.

11. PERFORMANCE:

i. All ancillary services shall be initiated within (3) three calendar days following receipt of a valid order, unless otherwise specified in the order.

ii. The Contractor shall not provide technical direction to Government personnel. Performance of the work under this agreement shall be subject to the technical direction of a Technical Point of Contact (POC) or Contracting Officer’s Representative (COR) which will be identified in the contract. The COR/POC is responsible for assuring that the Contractor’s performance proceeds in accordance with the terms of the agreement.

iii. No Government personnel, other than the Contracting Officer, will have the authority to provide clarification of technical points or supply relevant information. Specifically, no requirements in this Statement of Work may be altered as a sole result of verbal clarification. All clarifications shall be in writing.

Primary Point of Contact:

12. NON-PERSONAL SERVICES: The Government and the Contractor(s) hereby understand and agree that the services to be delivered under this agreement by the Contractor to the Government are non-personal services, and the parties recognize and agree that no employer-employee relationship exist or will exist under this agreement between the Government and the Contractor’s employees.

13. PERIOD OF PERFORMANCE: The period of service for this agreement shall commence on the date of award and continue with 5 option years, unless terminated earlier pursuant to the terms of this agreement.

14. INDIVIDUALS AUTHORIZED TO PLACE DELIVERY ORDERS: Any VA Contracting Officer or Prosthetic Purchasing Agent is authorized to place orders.

15. ORDER FORMAT: Orders will be placed against the multiple award contracts via FAX, hardcopy

OR electronic format. Each individual Delivery Order will describe the services and deliverables required.

16. AUTHORIZED REPRESENTATIVES: Performance of the work under this agreement shall be subject to the technical direction of a Contracting Officer’s Representative (COR). The COR is responsible for assuring that the Contractor’s performance proceeds in accordance with the terms of the agreement.

a. The COR will be responsible for technical monitoring of the contractor's performance and deliveries. The COR shall ensure all contractual requirements are being met. The COR will interpret specifications or technical portions of the work.

b. The COR is not authorized to perform, formally or informally, any of the following actions:

i. Promise, award, agree to award, or execute any agreement, modification, or notice of intent that changes or may change this agreement;

ii. Waive or agree to modification of the delivery schedule;

iii. Make any final decision on any matter subject to the Disputes Clause;

iv. Terminate, for any reason, the Contractor's right to proceed;

v. Obligate in any way, the payment of money by the Government. Only a warranted Contracting Officer / Government Purchase Card accountholder is authorized to obligate funds on this or any other contract action.

c. The Contractor(s) shall immediately notify the Contracting Officer in writing if the COR has taken an action (or fails to take action) or issues directions (written or oral) that the Contractor considers to exceed the above limitations.

d. The Contractor(s) shall provide the Contracting Officer information copies of all correspondence to the COR.

17. MANAGEMENT CONTROL: The Contractor(s) shall provide to the Contracting Officer (CO) a list of all teaming partners or subcontractors within 10 calendar days after order award. As subcontractors and/or teaming partners are added, and/or deleted, an updated listing will be provided to the CO within 10 calendar days of such change. All Contractors’ personnel shall display identification badges at all times at a Government location. Authorized Government personnel shall accompany all visits to Department of Veterans Affairs Program Offices unless other specific arrangements have been made.